By Stewart Eisenhart, Emergo Group
A new proposal by the US Food and Drug Administration would allow faster market authorization for some high-risk medical devices targeting diseases that cannot be treated by current approved technologies.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
A new proposal by the US Food and Drug Administration would allow faster market authorization for some high-risk medical devices targeting diseases that cannot be treated by current approved technologies.
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants.
By Stewart Eisenhart, Emergo Group
By Stewart Eisenhart, Emergo Group
India’s drug and medical device market regulators will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014.
By Stewart Eisenhart, Emergo Group
The Brazilian government has implemented a new law, RDC 15/2014 (link in Portuguese), that significantly eases the registration process for certain low-risk medical devices and IVDs.
Class I and II devices: BGMP no longer required
By Stewart Eisenhart, Emergo Group
Costa Rican medical device regulators are preparing a system to facilitate online registration of medical devices in a move to drive up foreign manufacturers’ interest in the Central American market.
By Stewart Eisenhart, Emergo Group
The Kingdom of Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has announced when medical device manufacturers must secure valid Medical Device Marketing Authorizations (MDMA) to legally continue selling their products in the KSA.
By Stewart Eisenhart, Emergo Group
A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned changes to the country’s medical device market regulatory system.